- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326768
Trial of Telmisartan 80 mg/HCTZ 12.5 mg and Telmisartan 40 mg/HCTZ 12.5 mg in Patients With Hypertension
An Open-Label, Long-term (52-week), Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg and Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recruitment period will be about three months from the start of the study.
Study Hypothesis:
The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed.
Comparison(s):
This study has no control group.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Hiroshima-shi, Hiroshima, Japan, 733-0011
- Boehringer Ingelheim Investigational Site
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Sapporo-shi, Hokkaido, Japan, 060-0003
- Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Essential hypertensive patients who meet the following criteria:
- In case of using any antihypertensives, mean seated DBP* must be over 90 and under 114 mmHg at Visit 1
- In case of not using any antihypertensives, mean seated DBP* must be over 95 and under 114 mmHg at Visit 1
- Mean seated DBP* must be over 90 at Visit 2 (* The mean DBP values will be calculated as the average of three seated measurements taken at two-minute intervals).
- Age over 20 and under 80 years at Visit 1 (Male or Female)
- Outpatient
- Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
- Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.
1. Patients taking four or more anti-hypertensive medications at Visit 1 2. Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.) 3. Patients whose mean seated DBP > 114 mmHg and/or mean seated SBP > 200 mmHg at Visit 1, Visit 2 or Visit 3 4. Patients with sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (AV-block II-III, atrial fibrillation etc.) 5. Patients with NYHA functional class heart failure III-IV 6. Patients with a history of myocardial infarction or cardiac surgery within last 6 3 months before signing the informed consent form 7. Patients with a history of coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within last 3 months before signing the informed consent form 8. Patients with a history of unstable angina within last 3 months before signing the informed consent form 9. Patients with hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve 10. Patients with a history of stroke or transient ischemic attack within last 6 months before signing the informed consent form 11. Patients with a history of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant 12. Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors 13. Patients with known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulfonamide-derived drugs (e.g. thiazides) 14. Known, suspected or history of gout
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: 52 weeks
|
52 weeks
|
Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
Time Frame: 52 weeks
|
52 weeks
|
Changes in electrocardiogram (ECG)
Time Frame: 52 weeks
|
52 weeks
|
Changes in blood pressure and pulse rate
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Seated Diastolic Blood Pressure (DBP) control rate
Time Frame: after 12 and 52 weeks
|
after 12 and 52 weeks
|
Seated Systolic Blood Pressure (SBP) control rate
Time Frame: after 12 and 52 weeks
|
after 12 and 52 weeks
|
Seated DBP response rate
Time Frame: after 12 and 52 weeks
|
after 12 and 52 weeks
|
Seated SBP response rate
Time Frame: after 12 and 52 weeks
|
after 12 and 52 weeks
|
Seated blood pressure (BP) normality criteria
Time Frame: after 12 and 52 weeks
|
after 12 and 52 weeks
|
Changes in seated DBP
Time Frame: after 12 and 52 weeks
|
after 12 and 52 weeks
|
Changes in seated SBP
Time Frame: after 12 and 52 weeks
|
after 12 and 52 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
- Telmisartan
Other Study ID Numbers
- 502.516
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Telmisartan 40 mg/HCTZ 12.5 mg
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Boehringer IngelheimCompleted
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Yuhan CorporationCompleted
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Boehringer IngelheimCompletedHypertensionFrance, Switzerland, Italy, Germany, Hong Kong, Netherlands, South Africa, Spain, Taiwan, Denmark, Sweden, Finland, Ireland, Korea, Republic of, Malaysia, Norway
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Boehringer IngelheimCompleted
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Menarini GroupDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyCompletedHypertensionPoland, Germany, Israel, Romania, Italy, Denmark, Czechia, Croatia
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George Medicines PTY LimitedCompletedHypertensionAustralia, United States, United Kingdom, Poland, Sri Lanka, New Zealand, Czechia
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Yuhan CorporationNot yet recruitingEssential HypertensionKorea, Republic of
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Boehringer IngelheimCompletedHypertension | Coronary ArteriosclerosisGermany
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Boehringer IngelheimCompletedDiabetic NephropathiesJapan
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Novartis PharmaceuticalsCompleted